Humodar K25-100 Rek (Suspension) Instructions for Use

Marketing Authorization Holder

Indar Private Joint Stock Company for Insulin Production (Ukraine)

ATC Code

A10AD01 (Insulin human)

Active Substance

Insulin human (Rec.INN registered by WHO)

Dosage Form

Humodar K25-100 Rek

Subcutaneous administration suspension 100 IU/1 ml: cartridges 3 ml 5 pcs., fl. 10 ml 1 pc.

Dosage Form, Packaging, and Composition

3 ml – cartridges (3) – cardboard packs.
3 ml – cartridges (5) – cardboard packs.
10 ml – vials (1) “insulin” – cardboard packs.

Clinical-Pharmacological Group

Intermediate-acting human insulin with rapid onset of action

Pharmacotherapeutic Group

Hypoglycemic agent – combination of short- and intermediate-acting insulins

Pharmacological Action

DNA-recombinant human insulin. It is an intermediate-acting insulin. It regulates glucose metabolism and has an anabolic effect. In muscle and other tissues (except the brain), insulin facilitates the intracellular transport of glucose and amino acids, and enhances protein anabolism. Insulin promotes the conversion of glucose into glycogen in the liver, inhibits gluconeogenesis, and stimulates the conversion of excess glucose into fat.

Indications

Diabetes mellitus when there are indications for insulin therapy; newly diagnosed diabetes mellitus; pregnancy in type 2 diabetes mellitus (non-insulin-dependent).

ICD codes

Dosage Regimen

Determine the dosage individually for each patient based on blood glucose levels.

Administer the suspension by subcutaneous injection only.

Inject the dose twice daily, approximately 30-45 minutes before the morning and evening meals.

Rotate injection sites within the same anatomical region to prevent lipodystrophy; suitable areas include the abdominal wall, thighs, buttocks, or upper arms.

Ensure the suspension is uniformly cloudy before administration; gently roll the vial or cartridge between your palms to resuspend the insulin. Do not shake vigorously.

Use the prescribed insulin delivery device (syringe or pen) that is compatible with the specific cartridge or vial packaging.

Adjust the dosage during intercurrent illness, emotional stress, or changes in physical activity and diet.

Monitor for the need for dosage adjustment when transferring a patient from another type of insulin; this adjustment may be immediate or occur gradually over several weeks.

Be aware that the insulin requirement may decrease in the presence of hepatic or renal impairment.

Be aware that the insulin requirement may decrease during the first trimester of pregnancy and increase during the second and third trimesters.

Instruct patients to recognize the symptoms of hypoglycemia and to take necessary precautions, especially when driving or operating machinery.

Adverse Reactions

Endocrine system: hypoglycemia.

Severe hypoglycemia can lead to loss of consciousness and (in exceptional cases) death.

Allergic reactions: local allergic reactions are possible – redness, swelling, or itching at the injection site (usually subside within a period from several days to several weeks); systemic allergic reactions (occur less frequently but are more serious) – generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, increased pulse rate, increased sweating. Severe cases of systemic allergic reactions can be life-threatening.

Contraindications

Hypoglycemia; hypersensitivity to insulin.

Use in Pregnancy and Lactation

During pregnancy, it is especially important to maintain good glycemic control in patients with diabetes mellitus. During pregnancy, the need for insulin usually decreases in the first trimester and increases in the second and third trimesters.

Patients with diabetes mellitus are advised to inform their doctor about the onset or planning of pregnancy.

In patients with diabetes mellitus during lactation (breastfeeding), adjustment of the insulin dose, diet, or both may be required.

In studies of genetic toxicity in in vitro and in vivo series, human insulin did not exert a mutagenic effect.

Use in Hepatic Impairment

The need for insulin may decrease in hepatic insufficiency.

Use in Renal Impairment

The need for insulin may decrease in renal insufficiency.

Special Precautions

Transferring a patient to another type of insulin or to an insulin preparation with a different trade name should occur under strict medical supervision.

Changes in insulin activity, its type, species (porcine, human insulin, human insulin analogue) or method of production (DNA-recombinant insulin or insulin of animal origin) may lead to the need for dose adjustment.

The need for dose adjustment may be required as early as the first administration of the human insulin preparation after an animal insulin preparation or gradually over several weeks or months after the transfer.

The need for insulin may decrease in cases of insufficient adrenal, pituitary, or thyroid function, or in renal or hepatic insufficiency.

In some diseases or during emotional stress, the need for insulin may increase.

Dose adjustment may also be required with increased physical activity or changes in the usual diet.

Symptoms that are precursors of hypoglycemia during the administration of human insulin may be less pronounced or different from those observed during the administration of animal insulin in some patients. When blood glucose levels normalize, for example, as a result of intensive insulin therapy, all or some of the precursor symptoms of hypoglycemia may disappear, and patients should be informed about this.

Precursor symptoms of hypoglycemia may change or be less pronounced in cases of long-term diabetes mellitus, diabetic neuropathy, or with the simultaneous use of beta-blockers.

In some cases, local allergic reactions may be caused by reasons not related to the effect of the drug, for example, skin irritation by a cleansing agent or improper injection technique.

In rare cases of systemic allergic reactions, immediate treatment is required. Sometimes a change of insulin or desensitization may be necessary.

Effect on ability to drive vehicles and operate machinery

During hypoglycemia, the patient’s ability to concentrate and the speed of psychomotor reactions may deteriorate. This can be dangerous in situations where these abilities are especially necessary (driving a car or operating machinery). Patients should be advised to take precautions to avoid hypoglycemia while driving. This is especially important for patients with mild or absent precursor symptoms of hypoglycemia or with frequent episodes of hypoglycemia. In such cases, the physician should assess the advisability of the patient driving a car.

Drug Interactions

The hypoglycemic effect is reduced by oral contraceptives, corticosteroids, thyroid hormone preparations, thiazide diuretics, diazoxide, and tricyclic antidepressants.

The hypoglycemic effect is enhanced by oral hypoglycemic drugs, salicylates (e.g., acetylsalicylic acid), sulfonamides, MAO inhibitors, beta-blockers, ethanol, and ethanol-containing preparations.

Beta-blockers, clonidine, and reserpine may mask the manifestation of hypoglycemia symptoms.

When insulin preparations are used in combination with drugs of the thiazolidinedione group in patients with type 2 diabetes mellitus, fluid retention in the body may occur, thereby increasing the risk of developing and progressing chronic heart failure, especially in patients with cardiovascular diseases and the presence of risk factors for chronic heart failure. Patients receiving such therapy should be regularly examined for signs of heart failure. If heart failure occurs, therapy should be carried out in accordance with current treatment standards.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.